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The Effects of Synbiotic on Cardiovascular and Bone Metabolism Markers in Transplanted Kidney Patients

NCT ID: NCT06160830

Last Updated: 2023-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-01

Study Completion Date

2024-05-01

Brief Summary

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The aim of this double-blind randomized clinical trial is to determine the effects of synbiotic supplement on cardiovascular disease risk factors and bone metabolism markers and depression, in transplanted kidney patients on chronic post-kidney transplant phase diet.This study is a double-blind, randomized controlled clinical trial with two parallel groups. 44 patients will be randomly assigned into synbiotic and control group. Transplanted kidney patients referring to the hospital clinics will be invited to participate. After assessing the entrance criteria, 7 cc blood samples are taken. The food recall is completed. Supplements are given to patients for 10-12 weeks. Serum concentrations of malondialdehyde; high sensitivity c-reactive protein; Soluble intercellular adhesion molecule-1; glucose; pentosidine; carboxy-methyl lysine; osteoprotegerin; Receptor activator of nuclear factor kappa-Β ligand; N-telopeptide; Intact parathyroid hormone; triglyceride; total cholesterol; High-density lipoprotein cholesterol; low-density lipoprotein cholesterol; lipoprotein-a; albumin; calcium; phosphorous; blood nitrogen urea; creatinine; and also systolic blood pressure; diastolic blood pressure; Weight; Body mass index; Waist circumference; Hip circumference; and questionnaires including quality of depression.

Detailed Description

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Conditions

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Transplanted Kidney

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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synbiotic

Patients in the synbiotic group will receive, for 10-12 weeks, Two capsules of synbiotic (Zist Takhmir Company) per day, each containing 500 mg of synbiotic. Patients in this group received a multispecies probiotic product (109 CFU/capsule) and fructo oligosaccharid as prebiotics.

Group Type ACTIVE_COMPARATOR

synbiotic

Intervention Type DIETARY_SUPPLEMENT

Two capsules of synbiotic per day, each containing 500 mg of synbiotic

placebo

Patients in the placebo group will receive Two capsules of placebo containing maltodextrin per day. The placebo powder will comparable in color, texture, and taste to the synbiotics. Supplement packaging will be done by Zist Takhmir Company.

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type OTHER

Two capsules of placebo containing maltodextrin per day

Interventions

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synbiotic

Two capsules of synbiotic per day, each containing 500 mg of synbiotic

Intervention Type DIETARY_SUPPLEMENT

placebo

Two capsules of placebo containing maltodextrin per day

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* : More than one year has passed since the last kidney transplant
* Having serum creatinine less than 2.5 mg/dL in the last three months
* Being in the age range of 18-75 years
* BMI\<35 kg/m2

Exclusion Criteria

* Receiving synbiotic supplement
Minimum Eligible Age

16 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Nutrition and Food Technology Institute

OTHER

Sponsor Role lead

Responsible Party

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zahra yari

faculty

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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zahra yari, PhD

Role: CONTACT

Phone: +982122357484

Email: [email protected]

Other Identifiers

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051

Identifier Type: -

Identifier Source: org_study_id